OTC Medication Information: Acetaminophen, Diphenhydramine Hydrochloride

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE- acetaminophen and diphenhydramine hydrochloride tablet, film coated
REMEDYREPACK INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep-aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • drowsiness will occur

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • children under 12 years: do not use

Other information

store at room temperature

croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

(800) 231-4670

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM Extra Strength.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DIST BY CAH, DUBLIN, OH 43017

1-800-200-6313

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Return to place of purchase if not satisfied

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Extra Strength Acetaminophen PM 500mg/25mg Tablet Oval Blue CPC752 supplied in:

NDC: 70518-2740-00 50 in 1 BOTTLE

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Acetaminophen, Diphenhydramine Hydrochloride

GENERIC: Acetaminophen, Diphenhydramine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2740-0

COLOR: blue

SHAPE: OVAL

SCORE: No score

SIZE: 17 mm

IMPRINT: CPC752

PACKAGING: 50 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1
  • ACETAMINOPHEN 500mg in 1

INACTIVE INGREDIENT(S):

  • TALC
  • TITANIUM DIOXIDE
  • STEARIC ACID
  • LIGHT MINERAL OIL
  • D&C YELLOW NO. 10
  • MAGNESIUM STEARATE
  • TRIACETIN
  • FD&C BLUE NO. 1
  • CROSCARMELLOSE SODIUM
  • POVIDONE K30
  • STARCH, CORN
  • SILICON DIOXIDE
  • HYPROMELLOSES
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
Remedy_Label
(click image for full-size original)
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen, diphenhydramine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-2740(NDC:70000-0411)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
TALC
TITANIUM DIOXIDE
STEARIC ACID
LIGHT MINERAL OIL
D&C YELLOW NO. 10
MAGNESIUM STEARATE
TRIACETIN
FD&C BLUE NO. 1
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
POVIDONE K30
STARCH, CORN
SILICON DIOXIDE
HYPROMELLOSES
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color blue Score no score
Shape OVAL Size 17mm
Flavor Imprint Code CPC752
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2740-0 50 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 05/12/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2020 REMEDYREPACK INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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